Achieving Regulatory Alignment for Anti-Infective Clinical Trials

Autor: Marco Cavaleri, Junko Sato, Sumathi Nambiar
Rok vydání: 2020
Předmět:
Zdroj: ACS Infectious Diseases. 6:1308-1310
ISSN: 2373-8227
Popis: The growing concern of antimicrobial resistance coupled with the dearth of new antibacterial agents in development is a major public health threat. Multiple stakeholder efforts are underway to address the various challenges facing this field; while some progress has been made, antibacterial drug development continues to be a challenging area. The economic issues encountered in this space are probably today the most cogent; however, there are many other aspects that continue to pose challenges to enterprises engaging in this area, from the difficulties in discovering and advancing new classes of products to scientific issues with clinical trial design and feasibility in conducting these trials.
Databáze: OpenAIRE